Recall StatusOpen, Classified
Date Initiated2026-02-06
Reason for Recall
Augmentation devices failed bacterial endotoxin testing.
Firm Action
On February 6, 2026, International Life Science ( subsidiary of Stryker) issued a Urgent: Medical Device Recall notification to affected consignees. International Life Science asked consignees to take the following actions:
1. Immediately check your internal inventory to locate the product, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use.
2. Review the product issue and risks as communicated and communicate the issue as appropriate in your organization.
3. Return the enclosed business reply form by email
a. Response is required, even if you may not have any physical inventory on site anymore.
4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s).
5. Maintain awareness of this communication internally until required actions have been completed within your facility.
6. If you have further distributed the affected product, please notify the applicable parties.
a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details, so that we can inform the recipients appropriately.
b. If you are a distributor, note that you are responsible for notifying your affected customers.
Root Cause
Process control
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.